Point-of-care triage and thermal treatment for cervical precancer with the IRIS device
POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency
This project tests a portable thermal ablation device plus an AI image triage tool to treat and prioritize HPV-positive women aged 30–49 with cervical precancer in El Salvador.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5000 (estimated) |
| Ages | 30 Years to 49 Years |
| Sex | Female |
| Sponsor | Basic Health International, Inc. Academic / other |
| Locations | 1 site (San Salvador, San Salvador Department) |
| Trial ID | NCT07461818 on ClinicalTrials.gov |
What this trial studies
The study prospectively enrolls 5,000 HPV-positive women aged 30–49 in El Salvador to receive a modified two-probe thermal ablation using the IRIS™ device with colposcopy and biopsies. The primary aim is to estimate one-year cure rates for CIN2+ after treatment with the modified IRIS probes in a single-arm interventional cohort. A retrospective component will apply an AI-based Automated Visual Evaluation (AVE) algorithm to IRIS images and compare its diagnostic performance against histopathology. Results will inform whether the probe modification improves treatment effectiveness and whether AVE could better identify women who need treatment.
Who should consider this trial
Good fit: Ideal candidates are non-pregnant women aged 30–49 who are HPV-positive through the national program, willing to undergo colposcopy and biopsies, and able to provide reliable contact information and informed consent.
Not a fit: Patients unlikely to benefit include pregnant women, those planning pregnancy during the study, individuals with recent LEEP or prior hysterectomy, women with a history of cervical cancer, HPV-negative people, or those unable to complete follow-up.
Why it matters
Potential benefit: If successful, this approach could expand access to effective same-day treatment and reduce progression to cervical cancer in low-resource settings.
How similar studies have performed: Portable thermal ablation has prior data showing safety and effectiveness in low-resource settings, while AVE-style AI triage methods are promising but still require independent validation against histopathology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 30-49 years * Non-pregnant (determined by urine pregnancy test) * HPV-positive per Ministry of Health (MOH) records * Willing to undergo colposcopy and biopsies * Able and willing to provide informed consent Exclusion Criteria: * Plans to become pregnant during the study * History of LEEP or cervical ablation procedure in the past 5 years * History of total hysterectomy (verified by medical record or pelvic evaluation) * History of cervical cancer * Unable or unwilling to provide a permanent and reliable address * Unable or unwilling to provide informed consent
Where this trial is running
San Salvador, San Salvador Department
- Basic Health International — San Salvador, San Salvador Department, El Salvador (Recruiting)
Study contacts
- Principal investigator: Karla Alfaro, MD — Basic Health International, Inc.
- Study coordinator: Karla Alfaro, MD
- Email: kalfaro@basichealth.org
- Phone: +503 22838731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.